Events

Tracheostomy tubes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arcadia Medical Corporation 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    61663
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1628-2012
  • 사례 시작날짜
    2012-04-18
  • 사례 출판 날짜
    2012-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108664
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Tube, tracheostomy (w/wo connector) - Product Code BTO
  • 원인
    A defect in 3 tracheostomy tubes. the defect observed was a separation in the bond between the proximal junction of the neck flange and the cannula.
  • 조치
    Arcadia notified the 3 consignees with a MEDICAL DEVICE VOLUNTARY RECALL notification dated 4/18/12. The notification identified the affected product, along with the reason for the recall. Consignees were instructed to cease distribution/use of any unopened product that they have remaining and return to firm following the steps provided. Arcadia will replace the product at no charge to the customer. Consignees were to confirm receipt of the recall notification by emailing Trena Depel, trena@arcadiamedical.com. Phone: 925-918-0595 Fax: (415) 762-5489

Device

Tracheostomy tubes
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 01103307 (50 units) and 01107055 (73 units)
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US, including Mariemount, OH and countries of UK and France.
  • 제품 설명
    Silicone Cuffed Wire Reinforced Extended Connect Pediatric Perfect Fit Neck Flange Tracheostomy Tube, Size 4.0 mm I.D. Catalog Number 353-040. || Intended for use in providing direct tracheal access for airway management.
  • Manufacturer
    Arcadia Medical Corporation

Manufacturer

Arcadia Medical Corporation
  • 제조사 주소
    Arcadia Medical Corporation, 1140 Millennium Dr, Crown Point IN 46307-7533
  • Source
    USFDA